Whether the TGA should publish that a prescription medicine is under evaluation

TGA

15 February 2019 - The TGA is seeking comments from interested parties on whether or not the TGA should in future disclose earlier that a prescription medicine is under evaluation and what types of prescription medicines should be published?

Medicines that are considered in scope for this consultation are prescription medicines that are lodged as applications for:

  • New medicines (new chemical entities, new biological prescription medicines, new fixed dose combinations).
  • New uses for medicines (extension of indications).
  • Generic or biosimilar medicines

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Michael Wonder

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Michael Wonder